Abstract

Background

Recent research has established correlations between stress, anxiety, insomnia and
excess body weight and these correlations have significant implications for health.
This study measured the effects of a proprietary blend of extracts of Magnolia officinalis and Phellodendron amurense (Relora®) on anxiety, stress and sleep in healthy premenopausal women.

Methods

This randomized, parallel, placebo controlled clinical study was conducted with healthy, overweight (BMI 25 to 34.9), premenopausal female adults,
between the ages of 20 and 50 years, who typically eat more in response to stressful
situations and scores above the national mean for women on self-reporting anxiety.
The intervention was Relora (250 mg capsules) or identical placebo 3 times daily for 6 weeks. Anxiety as
measured by the Spielberger STATE-TRAIT questionnaires, salivary amylase and cortisol
levels, Likert Scales/Visual Analog Scores for sleep quality and latency, appetite,
and clinical markers of safety. The study was conducted by Miami Research Associates,
a clinical research organization in Miami, FL.

Results

The intent-to-treat population consisted of 40 subjects with 26 participants completing
the study. There were no significant adverse events. Relora was effective, in comparison
to placebo, in reducing temporary, transitory anxiety as measured by the Spielberger
STATE anxiety questionnaire. It was not effective in reducing long-standing feelings
of anxiety or depression as measured using the Spielberger TRAIT questionnaire. Other
assessments conducted in this study including salivary cortisol and amylase levels,
appetite, body morphology and sleep quality/latency were not significantly changed
by Relora in comparison to placebo.

Conclusion

This pilot study indicates that Relora may offer some relief for premenopausal women
experiencing mild transitory anxiety. There were no safety concerns or significant
adverse events observed in this study.